Search Results for Prescribing Information

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FDA Offers Recommendations on Highlights Section of Labeling By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling

Tags: Highlights, Prescribing Information, Physician Labeling Rule

ABPI Extends Astellas UK Suspension for 12 More Months By Zachary Brennan - Published 28 June 2017

The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety."

Categories: News, Europe, Compliance, Crisis management, Ethics

Tags: ABPI, Astellas, prescribing information

FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically By Alexander Gaffney, RAC - Published 16 December 2014

In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.

Categories: News, US, CDER, Advertising and Promotion, Biologics and biotechnology, Drugs, Labeling

Tags: Drug Labeling, Proposed Rule, Rule, Regulation, Proposed Regulation, Professional Labeling, Prescribing Information